RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Risankizumab for Crohn's Disease

Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, how well it works, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies.

Official registry: https://clinicaltrials.gov/study/NCT05995353 · AbbVie · enrollment listed as 110

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Risankizumab, or Risankizumab. The registry lists allocation as randomized. Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever.

They plan to enroll about 110 people at 85 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Crohn's Disease

Interventions: Risankizumab, Risankizumab

Primary outcome (registry wording): Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission

Who it is for (from inclusion criteria)

Ages 2 Years to 17 Years
Pediatric individuals, 2 to \< 18 years old
Must have moderately to severely active CD, as defined by the PCDAI score \> 30 assessed at Baseline
Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)

Who the registry excludes

History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class
Any of the following medical disorders:
Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD
A diagnosis of CD prior to 2 years of age
A diagnosis or suspected diagnosis of a primary immunodeficiency
Currently known complications of CD such as:
Active abscess (abdominal or perianal);

Public study contact (from the registry)

ABBVIE CALL CENTER

844-663-3742

abbvieclinicaltrials@abbvie.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

85 listed

Phoenix Children's Hospital /ID# 255766 — Phoenix, Arizona (recruiting)
Arkansas Children's Hospital /ID# 255762 — Little Rock, Arkansas (completed)
UCSF Benioff Children's Hospital - Oakland /ID# 258327 — Oakland, California (recruiting)
Children's Hospital Colorado - Aurora /ID# 255764 — Aurora, Colorado (recruiting)
Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437 — Orlando, Florida (recruiting)
Indiana University Health Riley Hospital for Children /ID# 256454 — Indianapolis, Indiana (recruiting)
Massachusetts General Hospital - Mass General Waltham /ID# 255767 — Waltham, Massachusetts (recruiting)
MNGI Digestive Health, P. A. /ID# 255366 — Minneapolis, Minnesota (recruiting)
Goryeb Childrens Hospital /ID# 256452 — Morristown, New Jersey (recruiting)
Icahn School of Medicine at Mount Sinai /ID# 254880 — New York, New York (recruiting)
Cleveland Clinic - Cleveland /ID# 256453 — Cleveland, Ohio (recruiting)

+ 74 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05995353 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05995353?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05995353?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary